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Study Evaluating the Efficacy and Safety of Pantoprazole in Infants With Symptomatic Gastroesophageal Reflux Disease (GERD)

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ClinicalTrials.gov Identifier: NCT00365300
Recruitment Status : Completed
First Posted : August 17, 2006
Results First Posted : January 7, 2010
Last Update Posted : May 4, 2010
Information provided by:

Study Description
Brief Summary:
To assess the efficacy of pantoprazole for the treatment of infants with symptomatic Gastroesophageal Reflux Disease (GERD).

Condition or disease Intervention/treatment Phase
Gastroesophageal Reflux Drug: pantoprazole Drug: Placebo Phase 3

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 129 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Treatment-Withdrawal Study of the Efficacy and Safety of Pantoprazole Sodium Enteric-Coated Granules in Infants (1 Through 11 Months) With Symptomatic GERD.
Study Start Date : September 2006
Primary Completion Date : November 2007
Study Completion Date : November 2007

Resource links provided by the National Library of Medicine

MedlinePlus related topics: GERD
U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
Active Comparator: Pantoprazole Drug: pantoprazole
Placebo Comparator: Placebo Drug: Placebo

Outcome Measures

Primary Outcome Measures :
  1. Number of Patients Withdrawn From Study Due to Lack of Efficacy. [ Time Frame: 4 weeks double-blind ]
    Lack of efficacy defined as 1 or more of the following occurring during the double blind treatment-withdrawal phase: significant worsening of gastroesophageal reflux disease (GERD) symptoms frequency, a diagnostic test (e.g., endoscopy) demonstrating worsening of esophagitis, maximal antacid intake for ≥ 7 continuous days, or severe GERD symptoms based on physician's judgment.

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   up to 11 Months   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • term or post term infants beyond the neonatal period of an age greater than 28 days but less than or equal to 11 months
  • clinical diagnosis of GERD
  • weight greater than 2.5 kg and less than or equal to 15 kg

Exclusion Criteria:

  • known history of upper GI anatomic disorders
  • history of acute life-threatening medical conditions
  • clinically significant medical conditions or laboratory abnormalities
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00365300

  Show 38 Study Locations
Sponsors and Collaborators
Wyeth is now a wholly owned subsidiary of Pfizer
Study Director: Medical Monitor Wyeth is now a wholly owned subsidiary of Pfizer
More Information

Responsible Party: Wyeth (Registry Contact: Clinical Trial Registry Specialist), Wyeth
ClinicalTrials.gov Identifier: NCT00365300     History of Changes
Other Study ID Numbers: 3001B3-329
First Posted: August 17, 2006    Key Record Dates
Results First Posted: January 7, 2010
Last Update Posted: May 4, 2010
Last Verified: April 2010

Keywords provided by Wyeth is now a wholly owned subsidiary of Pfizer:
Gastroesophageal Reflux

Additional relevant MeSH terms:
Gastroesophageal Reflux
Esophageal Motility Disorders
Deglutition Disorders
Esophageal Diseases
Gastrointestinal Diseases
Digestive System Diseases
Anti-Ulcer Agents
Gastrointestinal Agents
Proton Pump Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action